Director, Regulatory & Compliance

Absci seeks a Director of Regulatory & Compliance to build and lead the regulatory affairs and compliance function from the ground up. This role encompasses regulatory strategy, ethics and compliance programs, data privacy governance, and government affairs, reporting to the CLO and CMO. The level may be adjusted based on candidate experience.

Responsibilities

• Build and maintain ethics and compliance program including policies, training, and monitoring mechanisms
• Develop and execute regulatory strategy across product development and commercial lifecycle
• Serve as primary liaison for FDA and international regulatory agency interactions and submissions
• Design and implement GDPR-ready data governance framework with DPIAs and privacy-by-design principles
• Lead internal investigations, audits, and corrective action processes; manage breach response protocols

Requirements

• Extensive experience in both regulatory affairs and compliance programs
• Demonstrated expertise in FDA and international regulatory strategy (EMA, ICH)
• Strong knowledge of GDPR, data privacy law, and data protection frameworks
• Experience leading ethics and compliance program development and implementation
• Familiarity with biotech regulatory landscape and emerging AI/ML guidance
• Track record managing regulatory agency interactions and submissions